Quality Manager Jobs

Job Summary

We are seeking a Quality Manager to oversee quality functions within our Regulatory and Quality Departments. In this role, you will manage daily inspections of product parts and assemblies, nonconformity management and investigations, and press and assembly quality, among other quality-related responsibilities. As part of this position, you will interact with various teams to support validation and revalidation projects, product sterilization management, manufacturing inspection scheduling, and regulatory affairs projects development and execution. You will play a vital role in meeting customer needs and expectations by developing new strategies to exceed customer satisfaction, creating project progress reports, statistical data analysis, and KPIs. This role will require a focus on existing product performance and new product development with project sustainability for validation, sterility, and regulatory affairs. You will be responsible for creating and modifying quality, regulatory, and manufacturing procedure documentation and assuring that quality and regulatory processes and related documentation follow established policies and procedures.

To be considered for this role, you must have a minimum of a two-year college degree in a relevant field or equivalent, with a bachelor's degree preferred. You should have at least four years of quality and manufacturing experience with supervisor, manager, coordinator, or group leader responsibilities, preferably in a medical device or pharmaceutical environment. You should have a demonstrated knowledge of NC/CAPA, MQA, medical device document control, GDP, cGMP, measurement theory for medical devices or injection molding, validation methods (IQ/OQ/PQ), statistical process control, application of statistical techniques, and meeting regulatory requirements per 21 CFR820/ISO 13485:2016. The ideal candidate should have experience with Six Sigma, process capability statistics, AQL, and a background in a medical device or pharmaceutical environment with FDA requirements. You must excellent written and verbal communication skills in English, along with a high level of attention to detail and accuracy.

location: Lake Geneva, Wisconsin

job type: Permanent

salary: $85,000 - 105,000 per year

work hours: 8am to 4pm

education: Bachelors

Responsibilities

• Perform functions to support quality management and company management team, and manage NC/CAPA trending efforts in quality and all secondary operations.
• Work with all departments to streamline and manage process steps, achieve continuous improvement progress, meet deadlines, and exceed customer satisfaction for periodic reviews, internal and supplier goods inspections, NC/CAPA trending, and calibration program management.
• Ensure timely reporting of regulatory requirements by working with Validation, Document Control, MQA, and QA/QC teams.
• Maintain calibration frequency for all calibrated instruments by executing and managing a schedule for metrology-related instruments and calibrations.
• Work with the internal audit team to perform an annual schedule of quality system audits.
• Coordinate changes to programs within and across all departments and customers, and create/write change requests, timelines, program requirements, KPIs, SOPs, and work instructions, including routing management signature of approval.
• Collaborate with quality department peers to provide documentation, statistical process, validation methodology, and services to meet customer and regulatory requirements as directed.
• Provide input and output for validation testing to support product development, identify project risks during R&D activities that can affect form, fit, function, and regulatory requirements for design, manufacturing, and quality.
• Support periodic reviews, sterilization dose audits, internal and external audit cycles, and regulatory affairs submissions and registration timing through master list activities. Assist in supplier and internal department audits, ensuring program timing meets FDA/medical (21 CFR820 and ISO 13485:2016) regulatory requirements.
• Partner with Manufacturing, Engineering, Quality, and Regulatory teams to communicate, analyze, investigate, implement, and document processes for quality control, quality assurance, nonconformity disposition, material review board, sterilization, validation, audits, and regulatory compliance. Develop procedures, SOPs, and protocols for project management.
• Generate and modify quality, regulatory, and manufacturing procedure documentation, and assure that quality and regulatory processes and related documentation follow established policies and procedures.
• Collaborate with various departments to ensure completion of routine production inspections within set timelines and goals, and establish responsibility and accountability for quality projects on the manufacturing floor.

The ideal candidate will have excellent communication and project management skills, attention to detail, and a commitment to meeting regulatory requirements and exceeding customer expectations. They will also demonstrate the ability to work effectively in a team environment, foster continuous improvement, and live the corporate values of treating people with dignity and respect, practicing leadership, driving for consensus, promoting innovation, and managing through teams.

Qualifications

• Minimum 3 years of experience
• Experience level: Manager
• Education: Bachelors (required)

Skills

• Quality

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.